Nasal dilator with variable spring rate

ABSTRACT

A nasal dilator strip and methods, the strip including a first layer including a cover having adhesive on a surface thereof, the cover having a first edge with a convex locating feature and a second edge opposite the first edge, the second edge being an uninterrupted edge, and a second layer having opposite surfaces, one opposite surface of the second layer being secured to the first layer, at least a portion of the other opposite surface of the second layer having adhesive to hold the two-layer nasal dilator strip in place on a user&#39;s nose, the second layer including a substantially planar resilient member, the resilient member having a constant thickness and longitudinal sides which converge from a center of the resilient member to a pair of spaced apart ends.

RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 11/880,217, filed on Jul. 19, 2007, the entirecontents of which are incorporated herein by reference.

BACKGROUND

This invention relates to an improvement to the configuration of nasaldilators such as those described in Spanish Patent No. 289,561 toIriarti dated 15 Sep. 1986 and in the further patents discussed below.Generally speaking these dilators employ a resilient band which has anadhesive on the bottom side and sufficient length so that the resilientband can be bent over the bridge of the nose, and each end of the bandbecomes adhesively attached to the soft tissue on the lateral wall ofthe nasal passage.

Bending the resilient band from its initial planar state to its deformedstate with its ends in contact with the lateral walls of the nasalpassages and the center of the band overlying the bridge of the noseresults in forces tending to pull out on the lateral wall tissues whichstabilize the walls of the nasal passages during breathing.

The present invention improves nasal dilators by providing them with aresilient member which has a variable spring rate that decreases fromthe point where the resilient band crosses the bridge of the nose to thepoint where the resilient band terminates at the lateral wall of thenasal passage.

The nasal dilator of the present invention has a soft fabric cushion ofthe same or a slightly greater thickness than the resilient member. Thesoft fabric cushion is located in the same layer as the resilient memberand covers the area of the soft fabric cover which is not in directcontact with the resilient member. The soft fabric cushion is in contactwith edges of the resilient member and prevents the edges of theresilient member from pressing into the skin on the user's nose whileusing the nasal dilator.

The present invention further provides a convex protrusion on the sideof the dilator at the center of the bridge of the nose facing the tip ofthe nose to indicate to the user the proper orientation of the dilatorwhen applying it to the nose.

Blockage of the nasal passages from swelling due to allergies, colds andphysical deformities can lead to breathing difficulty and discomfort.The nasal passages have mucus membranes which condition the air in thenasal passages prior to its arrival in the lungs. If the nasal passagesare constricted due to swelling or minor deformities then thealternative is to breathe through the mouth. This means that the airbypasses the mucus membranes, losing the conditioning effects andcausing irritation in the throat and lungs. At night, restrictions tobreathing through the nasal passages can lead to snoring and/or sleepdisturbances. In some cases, the restricted air supply can cause sleepproblems brought on by a lack of oxygen.

For people with chronic blockages in the nasal passages, the alternativeto correct the problem has been expensive surgery or medication. Peoplewith minor deformities and breathing problems brought on by swelling ofthe walls of the nasal passageways have been turning to various productsfitted in or on the nose which claim to open the nasal passages.

The structure of the nose limits the options available for the design ofnasal dilators. The nose terminates at the nostril, which has a slightlyexpanded volume immediately above it known as the vestibule. Above thevestibule, the nasal passage becomes restricted at a point called thenasal valve. At the nasal valve, the external wall of the nose consistsof soft skin known as the lateral wall, which will deform with airpressure changes induced within the nasal passage during the breathingcycles. Above the nasal valve the nasal passage opens up to a cavitywith turbinates over the top of the palate and turns downward to jointhe passage from the mouth to the throat.

The external structure of the nose consists of a skin covering over thenasal bones which are part of the skull. This gives the top of the nosea rigid structure at its base. Beyond the rigid nose bones, there isthin cartilage under the skin which is attached to the septum, which inturn contributes to the outside shape of the nose. The septum forms thewall between the two nostrils and may, if it is crooked, contribute tobreathing problems.

As an alternative to surgery, the structure of the nose and the currentart leave two main alternatives for the design of nasal dilators. Onealternative uses a tube or a similar structure which can be insertedinto the nasal passage to hold it in the open position allowing the freepassage of air. The disadvantage to this design is that the dilatorstructure covers up the mucus membranes which condition the air. Alsodilators of this design are uncomfortable and can irritate the walls ofthe nasal passage.

Another alternative is a dilator design, taught by the Iriarti patentfor example, where each end that attaches to the external lateral wallof each of the nasal passages has resilient means connecting the endsfor developing an external pulling force on the lateral wall causing itto open the nasal passage. This design has the advantage over the firstalternative because the nasal passages are not disturbed by an internalinsert. This design has limited control over the resilient force on thelateral wall of each of the nasal passages, and the resilient memberscrossing over the bridge of the nose can cause discomfort.

The present invention is an improvement over earlier nasal dilatorconfigurations because it redistributes the lifting forces within theresilient band by modifying the spring rate, so that they can provideoptimum lift on the lateral walls of the nasal passage. In additionmaximum comfort for the user is achieved by adding the cushion layer atthe same level as the resilient member to prevent the edge of theresilient member from pressing into the skin on the user's nose.

There is prior art which permits for adjusting the spring rate of theresilient band in the nasal dilator. For example, U.S. Pat. No.5,476,091 to Johnson employs two parallel resilient bands of constantwidth and constant thickness which cross over the bridge of the nose andterminate at the outer wall of each nasal passage. The Johnson patentshows a plurality of notches cut into the top of each end of theresilient band to reduce the spring rate, which in turn prevents the endof the resilient band from peeling away from the skin. Each notch is asingle point reduction of the spring rate with the spring rate reductiondetermined by the depth of the notch.

U.S. Pat. No. 5,479,944 to Petruson and U.S. Reissue Pat. No. Re 35,408to Petruson provide nasal dilators with a one-piece molded plasticstrip, the ends of which carry tabs for insertion into the nostrils.

U.S. Pat. No. 5,611,333 to Johnson shows the same concept of singlepoint reduction in the spring rate of the resilient band using thenotches shown in U.S. Pat. No. 5,476,091 mentioned above. In addition,the '333 Johnson patent shows other designs for the resilient band witheither holes or slots which are located at the ends of the resilientbands and are intended to reduce the spring rate at a single point toprevent the end of the resilient band from peeling away from the skin.

U.S. Pat. No. 6,029,658 to Voss shows a beam-shaped resilient band whichextends from one side of the user's nose across the bridge of the noseto the other side of the nose. The resilient band is made of plastic andhas a varying thickness and width over the entire span. The resilientband exhibits a rigidity increase from the center towards the tworespective ends which attach to the sides of the user's nose, which isthe exact opposite of what is attained with the present invention.

U.S. Pat. No. 6,453,901 to Ierulli discloses several nasal stripconfigurations where the cover member extends beyond the perimeter ofthe spring member, including one embodiment in which the strip has somedegree of variation in the spring force over a portion of the length ofthe strip.

Some of the better known nasal dilator patents, such as U.S. Pat. No.5,533,499 to Johnson, U.S. Pat. No. 5,533,503 to Doubrek et al., andU.S. Pat. No. 6,318,362 to Johnson, all teach of nasal dilators with acushion layer between the resilient member and the user's skin. U.S.Pat. No. 6,058,931 to Muchin is similar to the Spanish Iriarti patent inthat the resilient member is in direct contact with the user's skin andno cushion layer is provided. These nasal dilators differ from thecurrent invention, which provides a cushion layer at the same level inthe nasal dilator structure which prevents the edge of the resilientmember from pressing into the user's skin, but at the same time does notprevent contact of the resilient member from the user's skin.

Even the most recent nasal dilator patents such as U.S. Pat. No.6,694,970 to Spinelli, U.S. Pat. No. 6,769,428 to Cronk et al., and U.S.Pat. No. 6,769,429 to Benetti do not have the resilient member with aconstantly varying spring rate which is diminishing from the centerlineto each end of the resilient member in combination with the cushionlayer located at the same level as the resilient member. U.S. Pat. No.7,114,495 to Lockwood does have the resilient member with a constantlyvarying spring rate which diminishes from the centerline to each end ofthe resilient member. However, it has a cushion layer under theresilient member. In contrast, the cushion layer of the nasal dilator ofthe present invention is at the same level as, and surrounds, theresilient member.

BRIEF SUMMARY OF THE INVENTION

An object of this invention is to provide a nasal dilator which exhibitsimproved performance relative to the nasal dilator known from the priorart.

An important feature of the present invention is to provide a softfabric cushion layer which is the same size and shape as the top softfabric cover and has adhesives on both sides. The cushion layer is atthe same level as the resilient member and equal to or slightly thickerthan the resilient member. As a result, the cushion layer and theresilient member are substantially flush where they meet. Since theresilient member is attached to the bottom of the top fabric cover byadhesives, the cushion layer surrounds the edge of the resilient memberand covers the remaining area of the top soft fabric cover not coveredby the resilient member. The adhesive on the bottom of the cushion layeris in contact with the skin on the user's nose when the dilator is inuse.

Another improvement feature of the present invention is to configure theresilient band to reduce the width gradually from the center of theresilient band towards each end in a way that gradually reduces thespring rate of the resilient band. The thickness of the resilient bandremains constant over its entire length, which simplifies the structurewhile keeping costs low.

A further improvement of the present invention is that the new dilatorhas a relatively greater width at its center with the shape of thebottom edge provided with a slight convex protrusion which points to thetip of the nose when the dilator is in use. The outer shape of thedilator is configured to optimize the location of the resilient memberover the soft tissues on the outer wall of the nasal passages where thedilating forces are most effective.

Other improvements provided by the present invention are the four slitsin the top soft fabric cover and the cushion layer at the boundary thatseparates the ends of the dilator from the intermediate structure whichconnects the ends of the dilator. The four slits are close toperpendicular to the longitudinal axis of the dilator and allow the topsoft fabric cover and cushion layer to conform to the many differentshapes of the outer walls of the nasal passages.

An additional improvement of the present invention is the use oftransparent materials for the top soft fabric cover, the resilientmember, and the cushion layer. Here too the cushion layer has athickness that is equal to or slightly thicker than the resilientmember. The normal color for the top soft fabric cover is tan; however,for sports applications the cover may be black or some other dark color.

The nasal dilator of the present invention is a significant unobviousimprovement over the prior art. Nasal dilators that have been in themarket for more than 10 years have a resilient member held in place onthe user's nose by a top cover that defines the length and width of thedilator as well as adds additional adhesive surface to overcome thestresses developed by the resilient member. Another nasal strip that hasbeen sold in the past has a resilient member sandwiched between a topsurface which defines the length and width of the dilator and a cushionlayer that covers the entire bottom surface of the top layer. Both ofthese dilators use current converting technology in their manufacturingprocess.

The improved nasal dilator of the present invention uses a newconverting technology that has not been available until now. The newconverting process requires that the resilient member be formed andlocated on the bottom surface of the top cover in a precise location. Atthe same time the cushion layer must have an opening cut and beprecisely indexed, so that the edges of the cushion layer match up tothe respective edges of the resilient member in order to achieve thecontiguous bottom surface required by the improved dilator. Thisimprovement in precision in the converting process is due tocomputer-controlled indexing, as well as a special webbing, which do notform part of the present application.

The improvements summarized above enhance the performance of the dilatorand make the dilator more comfortable for the user as compared to priorart dilators in general and the Iriarti dilator in particular. Inanother embodiment the invention provides a method of {text}.

BRIEF DESCRIPTION OF THE DRAWINGS

The unique advantages of the present invention will become apparent toone skilled in the art upon reading the following specification and byreference to the following drawings:

FIG. 1 is a side view of the dilator on the nose;

FIG. 2 is an exploded perspective top view of the components making upthe dilator;

FIG. 3 is a top view of the dilator with a single resilient band;

FIG. 4 is a sectional view of the dilator in FIG. 3 showing the layersof the components that make up the dilator;

FIG. 5 is a top view of the dilator with two resilient bands;

FIG. 6 is a sectional view of the dilator in FIG. 5 showing the layersof the components that make up the dilator; and

FIG. 7 is a drawing showing the force vectors of the dilator in thisinvention compared to the force vectors in other, known dilators.

DETAILED DESCRIPTION

The specific improvements provided by this invention over past nasaldilators described in the prior art are best seen in the attacheddrawings.

Referring to FIGS. 1-4, the new nasal dilator 10 is mounted on the nose70 of the user. The nasal dilator 10 has a center 11 that is bent overthe bridge 71 of the nose 70, and each end 12 and 13 of the nasaldilator 10 is positioned over the lateral wall 72 of the nose 70.

The lateral wall 72 of the nasal passage 75 is located in the softtissue 73 above the nostril flare 74, which in turn is adjacent to theentrance of the nasal passage 75. When the nasal dilator 10 whichcontains a resilient band 30 is deformed from its normally planar stateby being bent over the bridge 71 of the nose 70, the ends 12 and 13which are attached to the lateral wall 72 of the nasal passage 75 tendto pull on the lateral wall 72 in a way that opens the nasal passage 75and improves the air flow through the nasal passages 75 duringbreathing. This invention shows improvements to the performance of thenasal dilator 10, makes the nasal dilator 10 easier to use, andincreases the comfort of the nasal dilator 10 when it is used to dilatethe lateral walls 72 of the nasal passages 75.

The new nasal dilator of the present invention has a top cover 20 whichestablishes the length and width of the nasal dilator 10, a resilientmember 30 which is attached to the bottom surface 22 of the top cover20, and a cushion layer 40 which is equal in thickness to the resilientmember 30 and covers all of the bottom surface 22 of the top cover 20that is not in contact with the top surface 38 of the resilient member30. The dilator is flat in its natural state with the thickness of thenasal dilator 10 that is constant over the entire surface of the topcover 20 including surfaces in contact with the resilient member 30 andthe cushion layer 40. The cushion layer 40 has an adhesive 43 which isin contact with the skin on the user's nose 70 when the nasal dilator 10is in use. The bottom surface 37 of the resilient member 30 does nothave an adhesive which is in contact with the skin on the user's nose70. The top cover 20 does not contact the skin on the user's nose 70when the nasal dilator 10 is in place, which is a unique feature of thenasal dilator of the present invention.

As is best seen in FIG. 2, the nasal dilator 10 is made up of severallayers. The first layer is the top cover 20 which is made from anon-woven polyester cellulose fabric or equal which is usually tan incolor on the top surface 21. The top surface 21 of the top cover 20 canbe dyed in any color or imprinted with a brand, logo or otherinformation. The top cover 20 also has a bottom surface 22 which iscoated with a 3 mils acrylic hypoallergenic medical gradepressure-sensitive type adhesive 25 or equal. The adhesive 25 covers theentire bottom surface 22 of the top cover 20.

The top cover 20 has two sides 23 and 24 which run over the length ofthe top cover 20 with the exception of an approximately 0.5-inch widesection at the center 11 of the nasal dilator 10. On one side 23 of thetop cover 20, there is a convex protrusion 26 which is configured toindicate the proper orientation of the nasal dilator 10 when it is inuse. When the nasal dilator 10 is properly positioned on the user'snose, the convex protrusion 26 at the center 11 of the nasal dilator 10is pointed towards the tip of the user's nose 70.

The second layer is the resilient member, 30, a plastic layer, which ismade from a polyester sheet which is about 0.010 inch to about 0.015inch thick, depending on the required strength of the nasal dilator 10.The thickness selected of the resilient member 30 is constant over theentire length of the resilient member 30, and the width of the resilientmember 30 is greatest at the center 31 where the nasal dilator 10 passesover the bridge of the nose 71. The bottom edge 33 of the resilientmember 30 curves toward the top edge 32 as the distance from the center31 of the resilient member 30 is increased. This reduction of the widthof the resilient member 30 causes a reduction of the spring rate in theresilient member 30 over the span from the center 31 to each of the ends34 and 35 of the resilient member 30. The width at the center 31 of theresilient member 30 is less than half of the width of the top cover 20,and the width of the resilient member 30 at each of the ends 34 and 35is approximately half of the width of the center 31.

The bottom edge 33 of the resilient member 30 between the center 31 andthe respective ends 34 and 35 is curved over the length of the strip andis asymmetrical in relation to the longitudinal center line 36 (see FIG.3) of the resilient member 30. Other curves for edges 32 and 33 arepossible as long as the maximum width of the resilient member 30 is atthe center 31 and the spring rate is reduced as the distance from thecenter 31 is increased until reaching ends 34 and 35. To attain thedesired force distribution and to prevent the development of torsionalforces, the radius of curvature of the edges 32 and 33 of the resilientmember 30 is greater than 1.5 inches. In addition, the thickness of theresilient member 30 is 3% or greater than the width of the resilientmember 30 at the longitudinal center line 36 in order to establish abaseline spring rate at the centerline of the resilient member 30 andallow for the reduction of width of the resilient member 30 over thespan to the ends 34 and 35 in which the polyester of specified thicknesswill achieve a lifting force of 25 to 30 grams. This ratio increases asthe distance from the center 31 is increased, and the width of theresilient band decreases until reaching ends 34 and 35.

In the same layer as the resilient member 30, there is a cushion layer40 which is equal to or slightly thicker than the resilient member 30and surrounds the edges 32 and 33 of the resilient member 30. In thisembodiment the edges 48 and 49 of the cushion layer 40 that are adjacentto the respective edges 32 and 33 of the resilient member 30 have thesame curvature as the resilient member 30 in order to form a contiguoussurface between the bottom 42 of the cushion layer 40 and the bottom 37of the resilient member 30. This will prevent the edge of the resilientmember 30 from pressing into the user's skin while the nasal dilator 10is in use.

The cushion layer 40 is made from non-woven polyester cellulose fabricwhich is about 0.010 inch to about 0.015 inch thick. The cushion layer40 is attached to the bottom surface 22 of the top cover 20 which is notcovered by the resilient member 30. As a result, the bottom 37 of theresilient member 30 and the bottom 42 of the cushion layer 40 are incontact with the skin on the user's nose 70, while the top cover 20cannot come in contact with the user's nose 70 when the nasal dilator 10is in use. This also distinguishes this present invention from the priorart because all known nasal dilators either have a cushion layer 40 thatprevents the resilient member 30 from contacting the skin on the user'snose 70 or have no cushion layer 40 which allows both the bottom surface22 of the top cover 20 and the bottom surface 37 of the resilient member30 to have direct contact with the skin on the user's nose 70.

The bottom 42 of the cushion layer 40 is coated with a 3 mils acrylichypoallergenic medical grade pressure-sensitive type adhesive 43 orequal that is designed to hold the nasal dilator in place on the user'snose 70. The adhesive 43 on the bottom 42 of the cushion layer 40 hassufficient strength when adhering to the user's nose 70 to overcome thestresses developed by the resilient member 30 when the resilient member30 is deformed to conform to the surface of the skin of the user's nose70. The cushion layer 40 has two sides 45 and 46 which match the tworespective sides 23 and 24 of the top cover 20. The cushion layer 40also has a convex protrusion 47 which matches the convex protrusion 26of the top cover 20.

A release liner 50 is provided to protect the adhesive surface 43 on thebottom side of the cushion layer 40. This release liner 50 is removedfrom the nasal dilator 10 prior to applying the nasal dilator 10 to theskin of the user's nose 70.

FIGS. 3 and 4 show a top view of the first embodiment of the nasaldilator 10 and a cross-sectional view (AA) which is perpendicular to thelongitudinal axis 36 of the nasal dilator 10. The cross-sectional viewshows the top cover 20 with adhesive 25 on the bottom surface 22 whichis in direct contact with the top surface 38 of the resilient member 30and the top surface 41 of the cushion layer 40. The edges 32 and 33 ofthe resilient member 30 are in direct contact with the edges 48 and 49of the cushion layer 40 forming a contiguous bottom surface 44 whichprevents the edges 32 and 33 of the resilient member 30 from pressinginto the skin on the nose 70 of the user when the nasal dilator 10 is inuse.

FIGS. 5 and 6 show a top view of another embodiment of the nasal dilator10 and its respective cross-sectional view (BB) which is perpendicularto the long axis of the nasal dilator 10. The edges 32 (A&B) and 33(A&B) of two resilient members 30 (A&B) are shown. The cross-sectionalview (BB) shows the top cover 20 with adhesive 25 on the bottom surface22 which is in direct contact with the top surface 38 (A&B) of theresilient members 30 (A&B) and the top surface 41 of the cushion layer40. The top cover 20 is made from non-woven polyester cellulose fabricor equal and the top cover 20 defines the length and width of the nasaldilator 10.

The second layer has two or more resilient members 30 (A&B) which aremade from a polyester sheet which is about 0.010 inch to about 0.015inch thick, depending on the required strength of the nasal dilator 10.The thickness selected of the resilient members 30 (A&B) is constantover the entire length of the resilient members 30 (A&B), so the nasaldilator 10 can be manufactured in a converting process. The width of theresilient members 30 (A&B) is constantly decreasing from the center 31(A&B) of the resilient members 30 (A&B) to each end 34 (A&B) and 35(A&B) in this particular embodiment, and the thickness of the resilientmembers 30 (A&B) is 3% or greater than the width of the resilient memberover the length of the nasal dilator.

As can be seen in FIG. 6, the resilient members 30 (A&B) are attached tothe bottom surface 22 of the top cover 20 with the adhesive 25 that isapplied to the bottom surface 22 of the top cover 20. The resilientmembers 30 (A&B) are parallel to the longitudinal axis 36 of the topcover 20 with each of the ends 34 (A&B) and 35 (A&B) terminating shortof the end edges of the top cover 20. The resilient members 30 (A&B)have no adhesive on the bottom surface which is in contact with theuser's skin when the nasal dilator 10 is in use.

Each of the resilient members 30 (A&B) can be symmetrical orasymmetrical to the longitudinal axis 39 (A&B) of the resilient members30 (A&B). Symmetry is achieved by using identical curves for sides 32(A&B) and 33 (A&B) between the center 31 (A&B) and the ends 34 (A&B) and35 (A&B) of the resilient members 30 (A&B). The concept of using areduction of the width in the resilient members 30 (A&B) that causes areduction of the spring rate in the resilient members 30 (A&B) can beused in nasal dilator 10 with one or more parallel resilient members 30(A&B) that extend parallel to the longitudinal axis 36 of the nasaldilator 10.

In the same layer as the resilient members 30 (A&B), there is a cushionlayer 40 which is equal to or slightly thicker than the resilientmembers 30 (A&B) and surrounds the edges 32 (A&B) and 33 (A&B) of theresilient members 30 (A&B). The cushion layer 40 is designed to form acontiguous surface between the bottom 42 of the cushion layer 40 and thebottoms 37 (A&B) of the resilient members 30 (A&B) to prevent the edges32 (A&B) and 33 (A&B) of the resilient members 30 (A&B) from pressinginto the user's skin while the nasal dilator 10 is in use. The cushionlayer 40 is made from non-woven polyester cellulose fabric which isabout 0.010 inch to about 0.015 inch thick including the thickness ofthe attached adhesive 43. The cushion layer 40 is attached to the bottomsurface 22 of the top cover 20 which is not covered by the resilientmembers 30 (A&B), and the edges 48 (A&B) and 49 (A&B) of the cushionlayer 40 are in contact with the respective adjacent edges 32 (A&B) and33 (A&B) of the resilient members 30 (A&B).

The bottom 42 of the cushion layer 40 is coated with a 3 mils acrylichypoallergenic medical grade pressure-sensitive type adhesive 43 orequal capable of withstanding the stresses caused by the resilientmembers 30 (A&B) and holding the nasal dilator 10 in place on the user'snose 70. Depending on the specific converting process used tomanufacture the nasal dilator 10, the cushion layer 40 may also have thesame 3 mils acrylic adhesive on the top surface 41 to control anystretch in the fabric during manufacturing.

To protect the adhesive surface 43 on the bottom surface 42 of thecushion layer 40, a release liner 50 is provided as shown in FIG. 2.This release liner 50 is pealed away exposing the adhesive 43 on thebottom of the cushion layer 40 when the nasal dilator 10 is ready to beplaced on the nose 70.

The nasal dilator 10 in both embodiments is normally in a planar statewhen it is removed from the release liner 50 and has no stresses. Whenthe nasal dilator 10 is bent over the bridge 71 of the nose 70 and theends 12 and 13 are engaged with the lateral wall 72 of the nasalpassage, then the stresses introduced in the resilient member 30 causethe ends 12 and 13 of the nasal dilator 10 to pull outwardly andupwardly on the lateral wall 72 to improve the breathing of the user.

The nasal dilator 10 in both embodiments can also be provided as a clearnasal dilator 10. In this case, the top cover 20 is made from a 3 milpolyethylene with the bottom surface 22 coated with 2 mils acrylichypoallergenic medical grade adhesive 25. The resilient member 30 inboth embodiments is made from the clear polyester and the cushion layer40 is made from 8 mil polyethylene with both the top surface 41 and thebottom surface 42 coated with 2 mils acrylic hypoallergenic medicalgrade adhesive 43.

Referring to FIGS. 1, 2, 3 and 5 there are four slits 52 in the top softfabric cover 20 and the cushion layer 40 at the boundary of the ends 12and 13 of the nasal dilator 10 and the intermediate structure 29 whichconnects the two ends 12 and 13. The four slits 52 are shown to beperpendicular to the longitudinal axis 36 of the nasal dilator 10, andthey allow the top soft fabric cover 20 and the cushion layer 40 toconform to the many different shapes of the outer wall tissue 73 of thenasal passages 75. In some cases the slits 52 may be cut at an angle tothe longitudinal axis 36 of the nasal dilator 10.

The use of a resilient band 30 with a decreasing spring rate in a nasaldilator 10 has a positive effect on the nasal dilator 10 performance.FIG. 7 shows a comparison of the performance of a nasal dilator 10 witha decreasing spring rate 60 on the left side of the vertical centerline55 and a nasal dilator with a constant spring rate 80 on the right sideof the vertical centerline 55. The nasal dilator 10 is shown bent overan elliptical surface 56 which represents the skin 76 of the user's nose70.

The nasal dilator 10 with the decreasing spring rate 60 has a series ofvectors 61 pulling out on the elliptical surface 56. Vectors 61 whichare further away from the vertical centerline 55 increase to vector 63.Then they begin to decrease to vector 64 at the end 12 of the nasaldilator 10. The vectors 61 on the side with the decreasing spring rate60 cause the lateral wall 72 to be pulled up and out at the center ofthe nasal passage 75, which improves the air flow in the nasal passage75. A reactive vector 65 provides an opposing force to vectors 61.

The right-hand side of FIG. 7 illustrates the forces generated by anasal dilator 10 with a constant spring rate 80. It generates a seriesof vectors 81 pulling out on the elliptical surface 56. As the vectors81 move away from the vertical centerline 55, they increase until thelast vector 83. This means that the pull on the lateral wall 72 isoutward and that the maximum vector 83 is pulling out on the lateralwall 72 at the edge of the nasal passage 75. Although air flow isimproved, the nasal dilator 10 with the decreasing spring rate 60provides better performance because it opens the lateral wall 72adjacent to the center of the nasal passage 75 where the maximum airvolume flows. Also the reactive vector 85 is greater than the reactivevector 65 for the decreasing spring rate 60 nasal dilator 10, whichrenders the constant spring rate 80 nasal dilator 10 less comfortablefor the user.

The description of the preferred embodiment described herein is notintended to limit the scope of the invention, which is properly set outin the claims.

1. A two-layer nasal dilator strip comprising: a first layer including acover having adhesive on a surface thereof, the cover having a firstedge with a convex locating feature and a second edge opposite the firstedge, the second edge being an uninterrupted edge; and a second layerhaving opposite surfaces, one opposite surface of the second layer beingsecured to the first layer, at least a portion of the other oppositesurface of the second layer having adhesive to hold the two-layer nasaldilator strip in place on a user's nose, the second layer including asubstantially planar resilient member, the resilient member having aconstant thickness and longitudinal sides which converge from a centerof the resilient member to a pair of spaced apart ends which, if forcedtogether from initial positions to reduce direct spacing between theends, results in restoring forces in the resilient member to restore thedirect spacing between the ends.
 2. The two-layer nasal dilator strip ofclaim 1 wherein the second layer also includes a cushion member.
 3. Thetwo-layer nasal dilator strip of claim 2 wherein the opposite surface ofthe cushion member has adhesive.
 4. The two-layer nasal dilator strip ofclaim 2 wherein the opposite surface of the resilient member does nothave adhesive.
 5. The two-layer nasal dilator strip of claim 1 whereinthe second edge of the cover is an uninterrupted linear edge.
 6. Thetwo-layer nasal dilator strip of claim 1 wherein the resilient member ismade of plastic.
 7. The two-layer nasal dilator strip of claim 6 whereinthe resilient member is made of polyester sheet material.
 8. Thetwo-layer nasal dilator strip of claim 1 wherein the resilient memberhas a thickness of about 0.010 of an inch to about 0.015 of an inch. 9.The two-layer nasal dilator strip of claim 1 wherein the cover and theresilient member are fabricated from transparent materials.
 10. Thetwo-layer nasal dilator strip of claim 1 wherein the resilient member issymmetrical with respect to a lateral centerline of the resilientmember.
 11. The two-layer nasal dilator strip of claim 1 wherein theresilient member is asymmetrical with respect to a longitudinalcenterline of the resilient member.
 12. The two-layer nasal dilatorstrip of claim 1 wherein the longitudinal sides of the resilient memberconverge from a lateral centerline to the ends.
 13. The two-layer nasaldilator strip of claim 1 wherein the resilient member has a spring ratewhich diminishes from the center to the ends.
 14. The two-layer nasaldilator strip of claim 13 wherein the resilient member has a constantlyvarying spring rate which diminishes from a lateral centerline of theresilient member to the ends.
 15. The two-layer nasal dilator strip ofclaim 1 wherein the resilient member generates restorative forcescapable of supporting a load of 25 to 30 grams applied to an end of theresilient member.
 16. A nasal dilator strip comprising: a cover havingadhesive on a surface thereof, the cover having a first edge with aconvex locating feature and a second edge opposite the first edge, thesecond edge being an uninterrupted edge; and a substantially planarresilient member secured to the cover, the resilient member having aconstant thickness and longitudinal sides which converge from a centerof the resilient member to a pair of spaced apart ends which, if forcedtogether from initial positions to reduce direct spacing between theends, results in restoring forces in the resilient member to restore thedirect spacing between the ends.
 17. The nasal dilator strip of claim 16wherein the nasal dilator strip is a two-layer nasal dilator strip, afirst layer including the cover and a second layer including theresilient member.
 18. The nasal dilator strip of claim 17 wherein atleast a portion of a surface of the second layer opposite the cover hasadhesive to hold the two-layer nasal dilator strip in place on a user'snose.
 19. The nasal dilator strip of claim 18 wherein the second layeralso includes a cushion member, the cushion member having the adhesiveto hold the two-layer nasal dilator strip in place on a user's nose. 20.The nasal dilator strip of claim 16 wherein the resilient member issymmetrical with respect to a lateral centerline of the resilientmember.
 21. The nasal dilator strip of claim 16 wherein the resilientmember is asymmetrical with respect to a longitudinal centerline of theresilient member.
 22. A two-layer nasal dilator strip comprising: afirst layer including a transparent cover having adhesive on a surfacethereof, the cover having a first edge with a convex locating featureand a second edge opposite the first edge, the second edge being anuninterrupted edge; and a second layer having opposite surfaces, oneopposite surface of the second layer being secured to the first layer,at least a portion of the other opposite surface of the second layerhaving adhesive to hold the two-layer nasal dilator strip in place on auser's nose, the second layer including a substantially planartransparent resilient member, the resilient member being made ofpolyester sheet material, the resilient member having a constantthickness of about 0.010 of an inch to about 0.015 of an inch, theresilient member having longitudinal sides which converge from a centerof the resilient member to a pair of spaced apart ends which, if forcedtogether from initial positions to reduce direct spacing between theends, results in restoring forces in the resilient member to restore thedirect spacing between the ends, the resilient member being symmetricalwith respect to a lateral centerline of the resilient member, theresilient member being asymmetrical with respect to a longitudinalcenterline of the resilient member, the resilient member having a springrate which diminishes from the center to the ends.
 23. The two-layernasal dilator strip of claim 22 wherein the second layer also includes acushion member.
 24. The two-layer nasal dilator strip of claim 23wherein the opposite surface of the cushion member has adhesive.
 25. Thetwo-layer nasal dilator strip of claim 23 wherein the opposite surfaceof the resilient member does not have adhesive.
 26. The two-layer nasaldilator strip of claim 22 wherein the second edge of the cover is anuninterrupted linear edge.
 27. The two-layer nasal dilator strip ofclaim 22 wherein the longitudinal sides of the resilient member convergefrom the lateral centerline to the ends.
 28. The two-layer nasal dilatorstrip of claim 22 wherein the resilient member has a constantly varyingspring rate which diminishes from a lateral centerline of the resilientmember to the ends.
 29. The two-layer nasal dilator strip of claim 22wherein the resilient member generates restorative forces capable ofsupporting a load of 25 to 30 grams applied to an end of the resilientmember.
 30. A method of manufacturing a two-layer nasal dilator strip,the method comprising: forming a first layer including a cover having afirst edge with a convex locating feature and a second edge opposite thefirst edge, the second edge being an uninterrupted edge; forming asecond layer having opposite surfaces, the second layer including asubstantially planar resilient member, the resilient member having aconstant thickness and longitudinal sides which converge from a centerof the resilient member to a pair of spaced apart ends which, if forcedtogether from initial positions to reduce direct spacing between theends, results in restoring forces in the resilient member to restore thedirect spacing between the ends; applying adhesive to a surface of thefirst layer; securing one opposite surface of the second layer to thefirst layer; and applying adhesive to at least a portion of the otheropposite surface of the second layer to hold the two-layer nasal dilatorstrip in place on a user's nose.
 31. The method of claim 30 furthercomprising applying a release liner to the other opposite surface of thesecond layer to protect the adhesive.
 32. The method of claim 30 whereinsecuring includes securing the resilient member substantially centeredon the cover.
 33. The method of claim 30 wherein forming the secondlayer includes forming a second layer including the resilient member anda cushion member.
 34. The method of claim 33 wherein applying adhesiveto at least a portion of the other opposite surface of the second layerincludes applying adhesive to the opposite surface of the cushionmember.
 35. The method of claim 33 wherein applying adhesive to at leasta portion of the other opposite surface of the second layer includes notapplying adhesive to the opposite surface of the resilient member. 36.The method of claim 30 wherein forming the first layer includes forminga cover with an uninterrupted linear second edge.
 37. The method ofclaim 30 wherein forming the second layer includes forming the resilientmember of plastic.
 38. The method of claim 37 wherein forming theresilient member includes forming the resilient member of polyestersheet material.
 39. The method of claim 30 wherein forming the resilientmember includes forming the resilient member with a thickness of about0.010 of an inch to about 0.015 of an inch.
 40. The method of claim 30wherein forming the first layer includes forming the cover of atransparent material, and wherein forming the second layer includesforming the resilient member of a transparent material.
 41. The methodof claim 30 wherein forming the second layer includes forming theresilient member asymmetrically with respect to a longitudinalcenterline of the resilient member.
 42. The method of claim 30 whereinforming the second layer includes forming the resilient membersymmetrically with respect to a lateral centerline of the resilientmember.
 43. The method of claim 42 wherein forming the resilient memberincludes forming the resilient member with the longitudinal sidesconverging from the lateral centerline to the ends.
 44. The method ofclaim 30 wherein forming the second layer includes forming the resilientmember with a spring rate diminishing from the center to the ends. 45.The method of claim 44 wherein forming the resilient member includesforming the resilient member with a constantly varying spring ratediminishing from a lateral centerline of the resilient member to theends.
 46. The method of claim 30 wherein forming the second layerincludes forming the resilient member to generate restorative forcescapable of supporting a load of 25 to 30 grams applied to an end of theresilient member.
 47. A method of introducing separating stresses innasal outer wall tissues of a user's nose, the method comprising:providing a two-layer nasal dilator strip including a first layerincluding a transparent cover, the cover having a first edge with aconvex locating feature and a second edge opposite the first edge, thesecond edge being an uninterrupted edge, and a second layer havingopposite surfaces, one opposite surface of the second layer beingsecured to the first layer, at least a portion of the other oppositesurface of the second layer having adhesive, the second layer includinga substantially planar transparent resilient member, the resilientmember being made of polyester sheet material, the resilient memberhaving a constant thickness of about 0.010 of an inch to about 0.015 ofan inch, the resilient member having longitudinal sides which convergefrom a center of the resilient member to a pair of spaced apart endswhich, if forced together from initial positions to reduce directspacing between the ends, results in restoring forces in the resilientmember to restore the direct spacing between the ends, the resilientmember being symmetrical with respect to a lateral centerline of theresilient member, the resilient member being asymmetrical with respectto a longitudinal centerline of the resilient member, the resilientmember having a spring rate which diminishes from the center to theends; orienting the two-layer nasal dilator strip on the user's nosewith the other opposite surface of the second layer facing a surface ofthe nose, with the first edge having the convex locating featurepointing toward a tip of the nose and with the second uninterrupted edgepointing away from the tip of the nose; bending the two-layer nasaldilator strip over a bridge of the nose; and attaching the adhesive tothe surface of the nose.
 48. The method of claim 47 wherein bendingincludes generating in the resilient member restoring forces capable ofsupporting a load of 25 to 30 grams applied to an end of the resilientmember.
 49. The method of claim 48 wherein attaching includes resistingthe restoring forces generated in the resilient member.